NCT01546038 · OUTCOME

AUCinf of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: ng*hr/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2

Analysis population: PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.

Groups in this outcome

Phase 1B: Glasdegib 100 mg + Decitabine

Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.

Phase 1B: Glasdegib 200 mg + Decitabine

Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Decitabine	4
Phase 1B: Glasdegib 200 mg + Decitabine	3

Reported measurements

Cycle 1/Day 1

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Decitabine	3
Phase 1B: Glasdegib 200 mg + Decitabine	3

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1B: Glasdegib 100 mg + Decitabine	133.4	71	Not reported	Not reported	Not reported
Phase 1B: Glasdegib 200 mg + Decitabine	251.5	140	Not reported	Not reported	Not reported

Cycle 1/Day 2

Analysis denominator · Participants

Group	Source count
Phase 1B: Glasdegib 100 mg + Decitabine	2
Phase 1B: Glasdegib 200 mg + Decitabine	2

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1B: Glasdegib 100 mg + Decitabine	NA	NA	Not reported	Not reported	Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCinf values are 265 and 1040 ng\*hr/mL.
Phase 1B: Glasdegib 200 mg + Decitabine	NA	NA	Not reported	Not reported	Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCinf values are 154 and 216 ng\*hr/mL.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
71
value
133.4
group Id
OG001
spread
140
value
251.5
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
Cycle 1/Day 1
categories
measurements
comment
Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCinf values are 265 and 1040 ng\*hr/mL.
group Id
OG000
spread
NA
value
NA
comment
Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCinf values are 154 and 216 ng\*hr/mL.
group Id
OG001
spread
NA
value
NA
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
units
Participants
title
Cycle 1/Day 2

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
id
OG000
title
Phase 1B: Glasdegib 100 mg + Decitabine
description
Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
id
OG001
title
Phase 1B: Glasdegib 200 mg + Decitabine

param Type

GEOMETRIC_MEAN

population Description

PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.

reporting Status

POSTED

time Frame

Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2

title

AUCinf of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2

type

SECONDARY

unit Of Measure

ng*hr/mL

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Preserved source evidence · Not medical advice